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Executive Summary
Pages 1-13

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From page 1...
... As a result, there is interest in developing methods to confine certain GEOs and their transgenes to specifically designated release settings. Many confinement methods, including induced sterilization and other methods, are biological in nature, whereas others rely on physical restrictions such as greenhouses or aquaculture pens.
From page 2...
... BANR and BLS organized the Committee on Biological Confinement of Genetically Engineered Organisms. The committee's charge was to review and evaluate bioconfinement methods and report on their application in confining transgenic crop plants, grasses, trees, fish, shellfish, and other organisms.
From page 3...
... Species that disperse easily can pose particular risks because of the inefficacy of physical confinement methods and because of the potential for escapees to interact with and harm wild populations. Currently, the most publicized environmental risk associated with transgene dispersal involves the evolution of increased weediness or invasiveness as a result of the sexual transfer of plant crop alleles to wild relatives.
From page 4...
... Plants Several existing methods target sexual and vegetative reproduction in plants. For example, sexual reproduction of genetically engineered plants can be blocked by including a gene that renders the organism either permanently sterile (nonreversible transgenic sterility)
From page 5...
... Microbes The two major bioconfinement methods used in microbes are phenotypic handicapping and the induction of suicide genes. The energetic cost of expressing the genetically engineered trait after phenotypic handicapping causes a loss in those organisms' ability to compete well with indigenous bacteria in soil and aquatic environments.
From page 6...
... Most of the bioconfinement methods for GEOs discussed in this report are in the early stages of development and much is yet to be understood. It is clear that there is a great need for additional information on how well bioconfinement methods work separately and together.
From page 7...
... An organism that is typically grown to produce a common and widespread food product probably would be a poor choice as a precursor for an industrial compound unless that organism were to be grown under stringent conditions of confinement. This is an important issue for any novel compound or GEO for which zero tolerance of bioconfinement failure is needed.
From page 8...
... Therefore, before a GEO is released, its bioconfinement techniques should be tested in appropriate environments and in representative genotypes under development, and the reproductive biology of the GEO should be elucidated relative to its progenitor. If a bioconfinement method is applied, the committee proposes that a new approach­­an integrated confinement system (ICS)
From page 9...
... The efficacy of bioconfinement will vary with the human processes involved in applying the technique; the confinement method itself; the characteristics of the GEO; the cost of compliance; the characteristics of the organizations involved; the regulatory system in place; and public transparency. The majority of the bioconfinement methods discussed in this report are in development and have not been used in conjunction with commercially available GEOs.
From page 10...
... Transparency and public participation should be important components in developing and implementing the most appropriate bioconfinement techniques and approaches. DETECTING AND MITIGATING BIOCONFINEMENT FAILURE Failures in the bioconfinement of GEOs have not been documented to date, in part because so few methods have been implemented.
From page 11...
... Those methods include growing male-sterile crops for hybrid seed production, small-scale rearing of sterile fish, and releasing sterile male insects that mate with wild females as part of biocontrol strategies to reduce pest insect populations. Two related areas of ecological concern about the use of bioconfinement with GEOs were identified: the large scale at which bioconfined organisms could be released and the possibility that even carefully planned, integrated bioconfinement methods could fail.
From page 12...
... It is difficult to generalize about the ecological effects of large-scale releases of bioconfined GEOs, and further research should address these questions in relation to specific realistic conditions. Research is needed to characterize potential ecological consequences of bioconfinement methods and to develop methods and protocols for assessing environmental effects should confinement fail.
From page 13...
... Such a system must be supported by a rigorous and comprehensive regulatory regime empowered with inspection and enforcement. Finally, in order to implement effective bioconfinement of GEOs, the committee recommends support for additional scientific research that · characterizes as completely as possible the potential ecological risks and consequences of a failure in bioconfinement · develops reliable, safe, and environmentally sound bioconfinement methods, especially for GEOs used in pharmaceutical production · designs methods for accurate assessment of the efficacy of bioconfinement · integrates the economic, legal, ethical, and social factors that might influence the application and regulation of specific techniques · models (using models that are calibrated and can be verified experimentally)


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